DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-12 and 15-20, in the reply filed on 07/29/2026 is acknowledged.
Claims 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claims 6 and 8 are objected to because of the following informalities:
Claim 6 should read “selected from the group consisting of mono-, di-, and oligo- polysaccharides” in lines 6-7 (currently the word “and” is after oligo-).
Claim 8 should read “selected from the group consisting of mono-, di-, and oligo- polysaccharides” in lines 3-4 (currently the word “and” is after oligo-). Appropriate correction is required.
Claim Rejections - 35 USC § 112, Second Paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6, 8, and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 6 and 8 are indefinite because they recite “medium chain triglycerides”. This term is indefinite because it is not clear how long the triglyceride chain must be to be considered “medium”.
Claim 19 recites the limitation “the hydroxypropyl cellulose" in lines 4 and 6. There is insufficient antecedent basis for this limitation in the claim because it is not clear whether (in each case) it is referring to the first hydroxypropyl cellulose or the second hydroxypropyl cellulose as introduced in claim 4. To overcome this rejection, the hydroxypropyl cellulose (in each case) can be defined as the “first” or the “second”.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 6-12, and 20 are rejected under 35 U.S.C. 103 as being as being obvious over Dormady et al. (US 2011/0262520 A1) in view of Keri et al. (US 2006/0154953 A1) and Tapolsky et al. (US 2013/0344127 A1).
Regarding claim 1, Dormady discloses a layered drug delivery device for transmucosal delivery of an active agent [abstract] [0001]. The drug delivery device contains three layers (Fig 2) [0051] with a first layer (backing layer), a second layer (drug containing layer), and an additional layer (adhesive layer) [0051]. The first layer (backing layer) includes a film forming polymer [0023]-[0025]. The second layer (active agent layer) includes a film forming polymer, such as hydroxypropyl cellulose, [0039] and an active agent [0036] [0038]. Dormady teaches that the active agent may be an antibiotic [0038]. The additional layer (adhesive layer) includes a mucoadhesive agent, such as polyvinyl pyrrolidone (an instantly disclosed laminating adhesive) [0045] and a permeation enhancer, such as polyethylene glycol (an instantly disclosed plasticizer) [0048] [0051].
It is prima facie obvious to combine prior art elements according to known methods, to yield predictable results. In the instant case, the claimed elements (e.g., hydroxypropyl cellulose in active agent layer; polyvinyl pyrrolidone and polyethylene glycol to be used in the additional (adhesive) layer) were known in the prior art (e.g., Dormady) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results (e.g., a layered drug delivery device) to one of ordinary skill in the art. MPEP 2143.A.
Dormady does not disclose that the active agent is a macrolide immunosuppressant, such as tacrolimus, or that the first (backing) layer includes ethyl cellulose.
Keri discloses a tablet containing amorphous tacrolimus [abstract]. Keri teaches that tacrolimus is an antibiotic [0004].
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In the instant case, since Dormady generally taught antibiotics as an active agent in a pharmaceutical delivery device, it is prima facie obvious to select tacrolimus for incorporation into the delivery device based on its recognized suitability for the intended use as an antibiotic active agent in a pharmaceutical delivery device, as taught by Keri.
The combined teachings of Dormady and Keri do not disclose that the backing layer includes ethyl cellulose.
Tapolsky discloses a pharmaceutical delivery device with an adhesive layer and a backing layer for drug delivery to mucosal surfaces [abstract]. Tapolsky teaches that ethyl cellulose is included in one or more layers of the delivery device as a component which acts to adjust the kinetics of the erodibility and provide a convenient manner of altering the release of the pharmaceutical and the lifespan of the device [0017].
Since Dormady generally teaches a multi-layered delivery device for drug delivery to mucosal surfaces, it would have been prima facie obvious to one of ordinary skill in the art to include ethyl cellulose, within the first (backing) layer of Dormady, because Tapolsky teaches that ethyl cellulose may be included in one or more layers of a delivery device for drug delivery to mucosal surfaces. An ordinarily skilled artisan would be motivated to use ethyl cellulose because Tapolsky teaches that ethyl cellulose acts as a component which adjusts the kinetics of the erodibility and provides a convenient manner of altering the release of the pharmaceutical and the lifespan of the device [0017].
Claim 2 is rendered prima facie obvious because it would have been obvious to include tacrolimus, as taught by Keri, within the teachings of Dormady, as previously discussed.
Claim 3 is rendered prima facie obvious because Dormady discloses that the second layer includes a therapeutic amount of a drug, such as an antibiotic [0036] [0038]. Dormady discloses that the drug is present in an amount of 1 to 50 wt.% of the second layer [0044], that the drug delivery device is from 0.5 to 4 cm wide by 0.5 to 6 cm long [0056], wherein the second layer makes up 90 wt. % to 10 wt. % of the layered drug delivery device [0057]. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. It would have been obvious to include tacrolimus, as taught by Keri, as the antibiotic disclosed by Dormady, as previously discussed.
Claim 6 is rendered prima facie obvious because Dormady discloses the first layer (backing layer) is water insoluble [abstract] and discloses that it further includes a plasticizer, such as propylene glycol, in an amount of 1-20 wt.% [0023] [0034] [0064]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 7 is rendered prima facie obvious because Dormady discloses that the additional layer (adhesive layer) may be disposed between the first (backing) and second (active agent) layer [0051].
Claim 8 is rendered prima facie obvious because Dormady discloses that the additional layer (adhesive layer) includes a permeation enhancer, such as polyethylene glycol (an instantly disclosed plasticizer) [0048] [0051].
Claim 9 is rendered prima facie obvious because Dormady discloses that the additional layer (adhesive layer) includes a mucoadhesive agent, such as polyvinyl pyrrolidone (an instantly disclosed laminating adhesive) [0045] [0051].
Regarding claim 10, Dormady does not disclose that the adhesive layer further comprises a film-forming polymer which is identical to the first film-forming polymer (the first film-forming polymer is defined in claim 1 to be ethyl cellulose).
Tapolsky discloses a pharmaceutical delivery device with an adhesive layer and a backing layer for drug delivery to mucosal surfaces [abstract]. Tapolsky teaches that ethyl cellulose is included in one or more layers of the delivery device as a component which acts to adjust the kinetics of the erodibility and provide a convenient manner of altering the release of the pharmaceutical and the lifespan of the device [0017].
Since Dormady generally teaches a multi-layered delivery device for drug delivery to mucosal surfaces, it would have been prima facie obvious to one of ordinary skill in the art to include ethyl cellulose, within the additional (adhesive) layer of Dormady, because Tapolsky teaches that ethyl cellulose may be included in one or more layers of a delivery device for drug delivery to mucosal surfaces. An ordinarily skilled artisan would be motivated to use ethyl cellulose in the adhesive layer because Tapolsky teaches that ethyl cellulose acts as a component which adjusts the kinetics of the erodibility and provides a convenient manner of altering the release of the pharmaceutical and the lifespan of the device [0017].
Claim 11 is rendered prima facie obvious because Dormady discloses that the additional layer (adhesive layer) may be disposed between the first (backing) and second (active agent) layer [0051] and that the drug delivery device comes in contact with the mucosal membrane [abstract]. Dormady discloses that the second layer (active agent layer) further comprises a plasticizer [0044] [0050].
Claim 12 is rendered prima facie obvious because Dormady discloses the drug delivery device is from 0.5 to 4 cm wide by 0.5 to 6 cm long [0056], wherein the first layer makes up 10 wt. % to 90 wt. % of the layered drug delivery device and the second layer makes up 90 wt. % to 10 wt. % of the layered drug delivery device [0057]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Regarding claim 20, Dormady does not disclose that the delivery device includes amorphous tacrolimus.
It would have been obvious to include tacrolimus, as taught by Keri, within the teachings of Dormady, as previously discussed.
Keri further teaches that the amorphous form of tacrolimus has better physical properties than the crystalline form such as improved dissolution and solubility [0022].
The ordinarily skilled artisan would be motivated to use amorphous tacrolimus because Keri teaches that the amorphous form of tacrolimus has better physical properties than the crystalline form such as improved dissolution and solubility [0022].
Claims 4 and 19 are rejected under 35 U.S.C. 103 as being as being obvious over Dormady et al. (US 2011/0262520 A1) in view of Keri et al. (US 2006/0154953 A1) and Tapolsky et al. (US 2013/0344127 A1) and further in view of Zerbe et al. (US 2003/0053962 A1) and as evidenced by “An In-depth Technical Guide to Ethylcellulose” (BenchChem Technical Support Team, 2026).
The 35 U.S.C. 103 rejection over Dormady in view of Keri and Tapolsky was previously discussed.
Regarding claim 4, Dormady does not disclose that the second film forming polymer is a mixture of ethyl cellulose, a first hydroxypropyl cellulose, and a second hydroxypropyl cellulose with the claimed molecular weights.
Tapolsky discloses a pharmaceutical delivery device with a layer which contains a pharmaceutical active ingredient for drug delivery to mucosal surfaces [abstract] [0046]. Tapolsky teaches that ethyl cellulose is included in one or more layers of the delivery device as a component which acts to adjust the kinetics of the erodibility and provide a convenient manner of altering the release of the pharmaceutical and the lifespan of the device [0017].
Since Dormady generally teaches a layered delivery device for drug delivery to mucosal surfaces, it would have been prima facie obvious to one of ordinary skill in the art to include ethyl cellulose, within active ingredient containing layer of Dormady, because Tapolsky teaches that ethyl cellulose may be included in one or more layers of a delivery device (such as the active ingredient containing layer) for drug delivery to mucosal surfaces. An ordinarily skilled artisan would be motivated to use ethyl cellulose because Tapolsky teaches that ethyl cellulose acts as a component which adjusts the kinetics of the erodibility and provides a convenient manner of altering the release of the pharmaceutical and the lifespan of the device [0017].
Further regarding claim 4, Tapolsky does not explicitly disclose that the substitution of ethoxyl groups in the ethyl cellulose is 48.0 to 49.5 %.
As evidenced by “An In-depth Technical Guide to Ethylcellulose” commercial grades of ethyl cellulose typically have an ethoxyl content of 44-48% (pg. 2). Therefore, because the prior art teaches ethyl cellulose, which is reasonably expected to be commercial grade, the properties the applicant discloses and/or claims (substitution of ethoxyl groups in the ethyl cellulose is 48.0 to 49.5 %) are reasonably expected to be necessarily present. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05 A.
While it is not disclosed that the substitution of ethoxyl groups is measured in accordance with ASTM D914 one of ordinary skill in the art would have a reasonable expectation of success, and without undue experimentation, in determining the substitution by methods known in the art (i.e., measuring in accordance with ASTM D914).
The combined teachings of Dormady, Keri, and Tapolsky do not disclose that the second film forming polymer includes a first hydroxypropyl cellulose and a second hydroxypropyl cellulose with the claimed molecular weights.
Zerbe discloses a delivery device for the oral cavity [abstract] with a mixture of hydroxypropyl cellulose GF (MW about 300,000) and hydroxypropyl cellulose EF (MW about 80,000) [0015] [0030]. Zerbe teaches that the hydroxypropyl cellulose improves the solubility properties of the film which enables disintegration of the film upon contact with moisture due to the water dissolution kinetics of hydroxypropyl cellulose [0014].
Since Dormady generally teaches a delivery device for the oral cavity, it would have been prima facie obvious to one of ordinary skill in the art to include the combination of hydroxypropyl cellulose GF (MW of about 300,000) and hydroxypropyl cellulose EF (MW of about 80,000), within the teachings of Dormady, because Zerbe teaches this combination of a first and second hydroxypropyl cellulose in a delivery device for the oral cavity. An ordinarily skilled artisan would be motivated to use this combination of hydroxypropyl cellulose because Zerbe teaches that the hydroxypropyl cellulose in the composition improves the solubility properties of the film which enables disintegration of the film upon contact with moisture due to the water dissolution kinetics of hydroxypropyl cellulose [0014]. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05 A.
Regarding claim 19, while the combined teachings of the prior art do not disclose the claimed amounts of the ethyl cellulose and the first and second hydroxypropyl cellulose in the active agent containing layer, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In regard to the ethyl cellulose, the general condition of ethyl cellulose in an active agent containing layer for a drug delivery device has been taught by the prior art (Tapolsky) and has been taught to affect the kinetics of the erodibility, release of the pharmaceutical, and the lifespan of the device [0017]. In regard to the hydroxypropyl cellulose, the general condition of hydroxypropyl cellulose in a film for oral delivery has been taught by the prior art (Zerbe) and has been taught to affect the solubility properties of the film [0014]. As such, it would not have been inventive for the skilled artisan to have discovered the optimum amount of ethyl cellulose and hydroxypropyl cellulose via routine experimentation to achieve the desired release profile and solubility properties of the film.
Claim 5 is rejected under 35 U.S.C. 103 as being as being obvious over Dormady et al. (US 2011/0262520 A1) in view of Keri et al. (US 2006/0154953 A1) and Tapolsky et al. (US 2013/0344127 A1) and as evidenced by “An In-depth Technical Guide to Ethylcellulose” (BenchChem Technical Support Team, 2026).
The 35 U.S.C. 103 rejection over Dormady in view of Keri and Tapolsky was previously discussed.
As discussed, it would have been prima facie obvious to one of ordinary skill in the art to include ethyl cellulose, as taught by Tapolsky, within the first (backing) layer of Dormady. While Tapolsky does not disclose the claimed amount of ethyl cellulose in the backing layer, Tapolsky does teach that ethyl cellulose acts to adjust the kinetics of the erodibility and provide a convenient manner of altering the release of the pharmaceutical and the lifespan of the device [0017]. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general condition of ethyl cellulose in a backing layer for a drug delivery device has been taught by the prior art (Tapolsky); as such, it would not have been inventive for the skilled artisan to have discovered the optimum amount of ethyl cellulose via routine experimentation to achieve the desired erodibility and the lifespan of the device.
Further regarding claim 5, Tapolsky does not explicitly disclose that the substitution of ethoxyl groups in the ethyl cellulose is 48.0 to 49.5 %.
As evidenced by “An In-depth Technical Guide to Ethylcellulose” commercial grades of ethyl cellulose typically have an ethoxyl content of 44-48% (pg. 2). Therefore, because the prior art teaches ethyl cellulose, which is reasonably expected to be commercial grade, the properties the applicant discloses and/or claims (substitution of ethoxyl groups in the ethyl cellulose is 48.0 to 49.5 %) are reasonably expected to be necessarily present. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05 A.
Claims 15-17 are rejected under 35 U.S.C. 103 as being as being obvious over Dormady et al. (US 2011/0262520 A1) in view of Keri et al. (US 2006/0154953 A1)
Regarding claim 15, Dormady discloses a layered drug delivery device for transmucosal delivery of an active agent [abstract] [0001]. The second layer (active agent layer) includes a film forming polymer, such as hydroxypropyl cellulose, [0039] and an active agent [0036] [0038]. Dormady teaches that the active agent may be an antibiotic [0038].
Dormady does not disclose that the layer comprises tacrolimus in amorphous form.
Keri discloses a tablet containing amorphous tacrolimus [abstract]. Keri teaches that tacrolimus is an antibiotic [0004]. Keri further teaches that the amorphous form of tacrolimus has better physical properties than the crystalline form such as improved dissolution and solubility [0022].
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In the instant case, since Dormady generally taught antibiotics as an active agent in a pharmaceutical delivery device, it is prima facie obvious to select tacrolimus for incorporation into the delivery device based on its recognized suitability for the intended use as an antibiotic active agent in a pharmaceutical delivery device, as taught by Keri. The ordinarily skilled artisan would have been motivated to use amorphous tacrolimus because Keri teaches that the amorphous form of tacrolimus has better physical properties than the crystalline form such as improved dissolution and solubility [0022].
Regarding claim 16, it would have been prima facie obvious to use amorphous tacrolimus, as taught by Keri, within the teachings of Dormady as previously discussed. Using the amorphous form of the drug would inherently result in the absence of X-ray diffraction peaks from the crystalline form.
Claim 17 is rendered prima facie obvious because Dormady discloses the drug delivery device includes an additional layer (adhesive layer) [0051]. The additional layer (adhesive layer) includes a mucoadhesive agent, such as polyvinyl pyrrolidone (an instantly disclosed laminating adhesive) [0045] and a permeation enhancer, such as polyethylene glycol (an instantly disclosed plasticizer) [0048] [0051].
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-12 and 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 15, and 18-20 of U.S. Patent Application No. 18/844,512 (notice of allowance mailed 06/22/2026) in view of Keri et al. (US 2006/0154953 A1) and Zerbe et al. (US 2003/0053962 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims recite all of the features instantly recited for the composition except for amorphous tacrolimus and the first hydroxypropyl cellulose and second hydroxypropyl cellulose.
Keri discloses a tablet containing amorphous tacrolimus [abstract]. Keri teaches that the amorphous form of tacrolimus has better physical properties than the crystalline form such as improved dissolution and solubility [0022].
Zerbe discloses a delivery device for the oral cavity [abstract] with a mixture of hydroxypropyl cellulose GF (MW about 300,000) and hydroxypropyl cellulose EF (MW about 80,000) [0015] [0030]. Zerbe teaches that the hydroxypropyl cellulose improves the solubility properties of the film which enables disintegration of the film upon contact with moisture due to the water dissolution kinetics of hydroxypropyl cellulose [0014].
It would have been prima facie obvious to one of ordinary skill in the art to include amorphous tacrolimus and the first hydroxypropyl cellulose and second hydroxypropyl cellulose within the claims. The ordinarily skilled artisan would have been motivated to formulate the composition to include tacrolimus as taught by Keri [abstract] [0022] and would have been motivated to use the amorphous form because Keri teaches that the amorphous form of tacrolimus has better physical properties than the crystalline form such as improved dissolution and solubility [0022]. The ordinarily skilled artisan would have been motivated to use the combination of a first and second hydroxypropyl cellulose because Zerbe teaches a combination of a first and second hydroxypropyl cellulose and that the hydroxypropyl cellulose improves the solubility properties of the film which enables disintegration of the film upon contact with moisture due to the water dissolution kinetics of hydroxypropyl cellulose [0014].
The weight percentages of each component, as recited in the instant claims, would be achieved by one of ordinary skill in the art through routine optimization. See MPEP 2144.05(II)(A).
Claims 1-12 and 15-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21, 23, and 30-32 of U.S. Patent Application No. 19/153,916 in view of Keri et al. (US 2006/0154953 A1) and Dormady et al. (US 2011/0262520 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The copending claims recite all of the features instantly recited for the composition except for the tacrolimus being in amorphous form and the adhesive layer including a laminating adhesive and a plasticizer.
Keri discloses a tablet containing amorphous tacrolimus [abstract]. Keri teaches that the amorphous form of tacrolimus has better physical properties than the crystalline form such as improved dissolution and solubility [0022].
Dormady discloses a layered drug delivery device for transmucosal delivery of an active agent [abstract] [0001]. The drug delivery device contains three layers (Fig 2) [0051] with a first layer (backing layer), a second layer (drug containing layer), and an additional layer (adhesive layer) [0051]. Dormady discloses the additional layer (adhesive layer) includes a mucoadhesive agent, such as polyvinyl pyrrolidone (a laminating adhesive) [0045] and a permeation enhancer, such as polyethylene glycol (a plasticizer) [0048] [0051].
It would have been prima facie obvious to one of ordinary skill in the art to include amorphous tacrolimus, a laminating adhesive and a plasticizer within the copending claims. The ordinarily skilled artisan would have been motivated to use the amorphous form of tacrolimus because Keri teaches that the amorphous form of tacrolimus has better physical properties than the crystalline form such as improved dissolution and solubility [0022]. The ordinarily skilled artisan would have been motivated to formulate the composition to include a laminating adhesive and a plasticizer as taught by Dormady [0045] [0048] [0051].
The weight percentages of each component, as recited in the instant claims, would be achieved by one of ordinary skill in the art through routine optimization. See MPEP 2144.05(II)(A).
This is a provisional nonstatutory double patenting rejection.
Claims 1-12 and 15-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-7, and 9-13 of U.S. Patent Application No. 18/410,464 in view of Keri et al. (US 2006/0154953 A1), Dormady et al. (US 2011/0262520 A1), and Zerbe et al. (US 2003/0053962 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The copending claims recite all of the features instantly recited for the composition except for the tacrolimus being in amorphous form, the adhesive layer including a laminating adhesive and a plasticizer, and the first hydroxypropyl cellulose and second hydroxypropyl cellulose.
Keri discloses a tablet containing amorphous tacrolimus [abstract]. Keri teaches that the amorphous form of tacrolimus has better physical properties than the crystalline form such as improved dissolution and solubility [0022].
Dormady discloses a layered drug delivery device for transmucosal delivery of an active agent [abstract] [0001]. The drug delivery device contains three layers (Fig 2) [0051] with a first layer (backing layer), a second layer (drug containing layer), and an additional layer (adhesive layer) [0051]. Dormady discloses the additional layer (adhesive layer) includes a mucoadhesive agent, such as polyvinyl pyrrolidone (a laminating adhesive) [0045] and a permeation enhancer, such as polyethylene glycol (a plasticizer) [0048] [0051].
Zerbe discloses a delivery device for the oral cavity [abstract] with a mixture of hydroxypropyl cellulose GF (MW about 300,000) and hydroxypropyl cellulose EF (MW about 80,000) [0015] [0030]. Zerbe teaches that the hydroxypropyl cellulose improves the solubility properties of the film which enables disintegration of the film upon contact with moisture due to the water dissolution kinetics of hydroxypropyl cellulose [0014].
It would have been prima facie obvious to one of ordinary skill in the art to include amorphous tacrolimus, a laminating adhesive and a plasticizer, and the first and second hydroxypropyl cellulose within the copending claims. The ordinarily skilled artisan would have been motivated to use the amorphous form of tacrolimus because Keri teaches that the amorphous form of tacrolimus has better physical properties than the crystalline form such as improved dissolution and solubility [0022]. The ordinarily skilled artisan would have been motivated to formulate the composition to include a laminating adhesive and a plasticizer as taught by Dormady [0045] [0048] [0051]. The ordinarily skilled artisan would have been motivated to use the combination of a first and second hydroxypropyl cellulose because Zerbe teaches a combination of a first and second hydroxypropyl cellulose and that the hydroxypropyl cellulose improves the solubility properties of the film which enables disintegration of the film upon contact with moisture due to the water dissolution kinetics of hydroxypropyl cellulose [0014].
The weight percentages of each component, as recited in the instant claims, would be achieved by one of ordinary skill in the art through routine optimization. See MPEP 2144.05(II)(A).
This is a provisional nonstatutory double patenting rejection.
Potentially Allowable Subject Matter
Claim 18 would be allowable if rewritten to overcome the double patenting rejection(s) set forth in this office action and to include all of the limitations of the base claim and any intervening claims.
The closest prior art (Dormady et al. US 2011/0262520 A1) is described above. Dormady does not disclose all of the limitations of claim 18 including a.) the backing layer having 55 to 95 wt.% of ethyl cellulose, 5 to 20 wt.% triacetin, and from 10 to 35 wt.% of a mixture consisting of about 19 wt.% polyvinylpyrrolidone, about 80 wt.% polyvinylacetate, about 0.8 wt.% sodium lauryl sulfate, and about 0.2 wt.% of silica, b.) the adhesive layer comprising from 70 to 90 wt.% of a mixture consisting of about 19 wt.% polyvinylpyrrolidone, about 80 wt.% polyvinylacetate, about 0.8 wt.% sodium lauryl sulfate, and about 0.2 wt.% of silica, and from 10 to 30 wt.% glycerin, and c.) the active agent-containing layer comprising at least 0.8 mg/cm2 of tacrolimus in amorphous form, ethyl cellulose in an amount of 25 to 35 wt.% of the active agent-containing layer, hydroxypropyl cellulose with a molecular weight of about 370,000 in an amount of 7 to 15 wt.% of the active agent-containing layer, hydroxypropyl cellulose with a molecular weight of about 80,000 in an amount of 30 to 45 wt.% of the active agent-containing layer, and a mixed calcium/sodium salt of a methyl vinyl ether and maleic anhydride copolymer as a further film-forming polymer in an amount of 2 to 5 wt.% of the active agent-containing layer.
The authors have demonstrated that a transmucosal therapeutic system with all of the claimed elements as recited in claim 18 was shown to provide sufficient mucoadhesion compared to comparative compositions (specification, pg. 28-31). The claimed transmucosal therapeutic system of claim 18 (and its beneficial mucoadhesion properties) is not suggested nor taught by the prior art.
Conclusion
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/ASHLEE E WERTZ/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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